Medical Device Recall: OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Boston Scientific Corporation · July 14, 2026
Reason for Recall
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Distribution
Worldwide distribution - US Nationwide and the countries of Austria, Azerbaijan, Belgium, Bulgaria, Canada, Chile, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Latvia, Malta, Netherlands, Norway, Pakistan, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, UAE, United Kingdom.
States Affected
NATIONWIDE
Quantity Affected
60,654 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2961-2026
Status: ongoing
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